Web Content Viewer (JSR 286)

Web Content Viewer (JSR 286)

FSIS Data Analysis and Reporting: Public Health Regulations

FSIS uses decision criteria to prioritize its Food Safety Assessments (FSAs). FSAs are in-depth evaluations of an establishment's food safety system. FSAs can be routine, or for cause. The decision criteria include factors such as pathogen testing results, recalls, outbreaks, regulatory findings, and inspection results. These criteria are described in detail in FSIS' Public Health Decision Criteria Report (PDF Only).

FSIS has revised one of those decision criteria to take advantage of new data collected through PHIS. The criterion formerly referred to as W3NRs was based on PBIS inspection findings and was temporarily suspended with the implementation of PHIS. In January, 2013, FSIS submitted to the National Advisory Committee on Meat and Poultry Inspection (NACMPI) its plans to implement an updated version of the W3NRs, now called the Public Health Regulations (PHRs). The proposal, a supporting report and NACMPI recommendations can be found on the NACMPI web pages.

FSIS implemented the PHR criterion starting with the May, 2013 cycle of FSA scheduling. FSIS reviews the list annually, as recommended by NACMPI, and making updates as needed. Updates will be announced around July 1 each year with a targeted implementation month of October.

Constructed, located and operated in a manner that does not deter inspection

416.3(c)

Receptacles for storing inedible material must identify permitted use

416.4(a)

Food contact surface, cleaning and sanitizing as frequency

416.4(d)

Product processing, handling, storage, loading, unloading, and during transportation must be protected

416.5(c)

Employees who appears to have any abnormal source of microbial contamination

417.2(c)

Contents of HACCP Plan

417.2(c)(4)

List of procedures and frequency

417.3(a)(1)

Identify and eliminate the cause

417.3(a)(2)

CCP is under control

417.3(a)(3)

Establish measures to prevent recurrence

417.3(a)(4)

No adulterated product enters commerce

417.3(b)(1)

Segregate and hold the affected product

417.3(b)(2)

Determine the acceptability of the affected product

417.3(b)(3)

Deviation not covered (unforeseen hazard)

417.3(b)(4)

Reassessment

417.3(c)

Document corrective actions

417.4(a)

Adequacy of HACCP in controlling food safety hazards

417.4(a)(1)

Initial validation

417.4(b)

Reassessment of hazard analysis

417.5(a)(1)

Written hazard analysis

417.5(a)(2)

Written HACCP plan

417.5(a)(3)

Records documentation and monitoring of CCP's and Critical Limits

417.5(f)

Official Review

430.4(a)

Lm, post-lethality exposed RTE

430.4(b)(2)

Alternative 2

430.4(b)(3)

Alternative 3

430.4(c)(2)

Lm, documentation that supports decision in hazard analysis

430.4(c)(3)

Lm, maintain sanitation in post-lethality processing environment

Compliance by establishments with these regulations will be evaluated and compared to cut points that have been set for three broad categories of establishment operations: Slaughter, Processing and Combination. The cut points are listed below.

Cut Points, Fiscal Year 2015

Operation Type

FY 2015 PHR Cut Points

FY 2014 PHR Cut Points

Processing

6.55%

6.09%

Combination

9.37%

9.21%

Note: For FY 2015, the Slaughter category has been combined with the Combination category.

Historical Information

Public Health Regulations List, Fiscal Years 2013-2014

Regulation
Verified

Description

301.2_Adulterated

The term adulterated applies to any carcass, part thereof, meat or meat food product under one or more of a number of circumstances (See 9 CFR).

310.22(e)(1)

Establishments that slaughter cattle or process the carcasses or parts of cattle must develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials.

310.22(e)(3)

Establishments that slaughter cattle or process the carcasses or parts of cattle must routinely evaluate the effectiveness of their procedures for the removal, segregation, and disposition of specified risk materials in preventing the use of these materials for human food and must revise the procedures whenever any changes occur that could affect the removal, segregation, and disposition of specified risk materials.

310.22(f)(2)

Use of routine operational sanitation procedures on equipment used to cut through SRMs if processing cattle under 30 months before cattle 30+ months

381.1_Adulterated

The term adulterated applies to any poultry product under one or more of a number of circumstances (See 9 CFR).

381.144(a)

Packaging materials not to be composed of any poisonous or deleterious substance

381.65(a)

Operations must adhere strictly to clean and sanitary practices; products must not be adulterated.

381.65(e)

Zero-tolerance for visible fecal material entering chiller

381.83

Septicemia or toxemia

381.91(a)

Certain contaminated carcasses to be condemned

381.91(b)

Reprocessing of carcasses contaminated with digestive tract contents must be under the supervision of an inspector and thereafter found not to be adulterated.

416.1

Operate in a manner to prevent insanitary conditions to ensure product is not adulterated.

Constructed, located and operated in a manner that does not deter inspection to determine sanitary condition.

416.4(d)

Product processing, handling, storage, loading, unloading, and during transportation must be protected.

416.6

Any room, compartment, equipment or utensil found insanitary or could create adulterated product must be marked with a US Rejected tag and cannot be used until made acceptable. Only FSIS program employee may remove "U.S. Rejected" tag.

417.2(c)(4)

List of procedures and frequency must be in the HACCP plan.

417.3(a)(1)

Identify and eliminate the cause.

417.3(a)(2)

CCP is under control.

417.3(a)(3)

Establish measures to prevent recurrence.

417.3(a)(4)

No adulterated product enters commerce.

417.3(b)(1)

Segregate and hold the affected product.

417.3(b)(3)

No adulterated product enters commerce.

417.3(c)

Document corrective actions.

417.4(a)

Adequacy of HACCP in controlling food safety hazards

417.4(a)(1)

Initial validation

417.4(a)(3)

Reassessment, at least annually or when necessary

417.4(b)

Reassessment of hazard analysis

417.5(a)(1)

Establishment shall maintain a written hazard analysis.

417.5(a)(3)

Records documentation and monitoring of CCPs and Critical Limits as prescribed in the HACCP plan

Compliance by establishments with these regulations will be evaluated and compared to cut points that have been set for three broad categories of establishment operations: Slaughter, Processing and Combination. The cut points are listed below.